An interventional study of Transcranial Magnetic Stimulation in Spontaneous Intracerebral Hemorrhage, sponsored by National University Hospital, Singapore. Recruiting at 2 sites in Singapore. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Treatment
Spontaneous intracerebral haemorrhage (ICH) is a devastating form of stroke accounting for approximately 10-15% of all strokes globally. There is increasing evidence of younger working-age adults suffering from small-to-moderate sized spontaneous ICH, who develop significant motor and cognitive impairment after the event. These impairments contribute substantially to post-stroke functional morbidity and poor recovery, increasing care needs and decreasing economic productivity.
Existing neuromodulation trials in stroke rehabilitation have applied transcranial magnetic stimulation (TMS) at fixed anatomical targets using group-level brain maps, which overlooks the substantial inter-individual variability in the spatial topography of functional brain networks after ICH. Precision functional mapping techniques have demonstrated that individual-specific brain networks can be estimated using densely sampled resting-state functional MRI (rs-fMRI) data and multi-session hierarchical Bayesian models (MS-HBM). These individual-specific networks can identify personalised neuromodulation targets for navigated TMS (nTMS) to improve rehabilitation outcomes.
Intermittent Theta Burst Stimulation (iTBS) to the primary motor cortex (M1) has been shown to alter functional connectivity in a dose-dependent manner, while iTBS to the dorsolateral prefrontal cortex (DLPFC) improves attention and memory after left-hemispheric stroke. Precision neuromodulation using nTMS targeting individual-specific functional M1 and DLPFC areas for personalised stroke rehabilitation has yet to be sufficiently tested in high-quality clinical trials.
The PREMANE trial aims to use precision functional mapping in individual patients with spontaneous intracerebral hemorrhage to investigate inter-individual connectivity changes over time and after navigated neuromodulation to deliver personalised neurorehabilitation for patients with ICH.
The investigators designed a randomised cross-over pilot trial of sham nTMS first or active nTMS first three-months after ICH followed by crossover after a three-week washout period. The patient, investigator, technician, and outcome assessor will be blinded to the patient's allocation in the trial. Each nTMS protocol lasts for one week (15 sessions per week for a total 30 sessions). nTMS consist of either the sham arm or active arm. Individual-specific nTMS targets will be localised using our pipeline for estimating high-quality individual-specific networks using fMRI. Standard care rehabilitation will be provided to all participants of the trial during the study period. Primary outcomes pre- and post-stimulation are measured using the Fugl-Meyer Upper Extremity Scale (FMA), Western Aphasia Battery (WAB), a detailed neuropsychological assessment that assess 6 cognitive sub-domains (cognition), Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT) and Paired associates learning (PAL). Functional outcomes will be assessed at baseline, 3-months, before and after each nTMS protocol, 6-months, and 1-year follow up. Secondary outcomes are changes in functional connectivity of brain networks using precision functional mapping techniques before and after each nTMS protocol.
National University Hospital, Singapore is the lead sponsor of 453 studies on the registry; 98 are open to participants now.
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Participants will be randomized into two groups to determine the sequence of intervention (active neuromodulation or sham stimulation first). Randomization will be performed using a computer-generated allocation sequence by an independent party not involved in outcome assessment. Sham stimulation will be provided by a sham coil. Active neuromodulation will be provided by an active coil. The active neuromodulation protocol utilizes intermittent theta burst stimulation (iTBS). The stimulation parameters include: * Intensity of 90% of resting motor threshold (RMT) * 3 sessions per day over 5 consecutive days * 1800 pulses per session
Device: Transcranial Magnetic Stimulation
Participants will be randomized into two groups to determine the sequence of intervention (active neuromodulation or sham stimulation first). Sham stimulation will be provided by a sham coil. Active neuromodulation will be provided by an active coil. The active neuromodulation protocol utilizes intermittent theta burst stimulation (iTBS). The stimulation parameters include: * Intensity of 90% of resting motor threshold (RMT) * 3 sessions per day over 5 consecutive days * 1800 pulses per session
Device: Transcranial Magnetic Stimulation
The trial intervention in this study is navigated transcranial magnetic stimulation (nTMS), a non-invasive neuromodulation technique used to modulate cortical activity. nTMS delivers focused magnetic pulses to targeted cortical regions, inducing electrical currents that can alter neuronal excitability and functional connectivity. In this study, stimulation targets will be individualized based on precision functional mapping derived from magnetic resonance imaging (MRI). The intervention will be delivered using an established intermittent theta burst stimulation (iTBS) protocol. Stimulation parameters will include an intensity of 90% of resting motor threshold (RMT), with multiple sessions administered per day over a defined treatment period. nTMS has a well-established safety profile when delivered within recommended guidelines. Common side effects include mild headache or scalp discomfort, while serious adverse events such as seizures are rare.
Fugl-Meyer Assessment: Upper Extremity
Time frame: Immediately after the intervention
Montreal cognitive assessment score (MoCA)
Time frame: Immediately after the intervention
Western Aphasia Battery
Time frame: Immediately after the intervention
Paired Associates Learning
Time frame: Immediately after the intervention
Trail Making Test
Time frame: Immediately after the intervention
Changes in functional connectivity
Time frame: Immediately after the intervention
All functional outcomes
Time frame: 6 months after the intervention
Plan to share: Undecided — IPD may be shared upon reasonable request, data security policy, and research collaboration agreements are in place.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2027, 16 months after the start.
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